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The Thai Journal of Pharmaceutical Sciences

Abstract

Good manufacturing practice (GMP) inspection of overseas manufacturers in Thailand is regulated under desktop inspection that is verified mainly by documents. Thus the inspection results may cause certain gaps in terms of quality and reliability, particularly when compared with on-site inspection. This work utilized the pharmaceutical quality risk management in the International Council for Harmonization Q9 guideline with Failure Mode and Effects Analysis (FMEA) tool to study and manage potential risks. The study design consisted of five steps. First, a pre-assessment step was to set up a team to consider a data analysis of the inspection data and drug quality defects. The risk identification step was performed by analyzing the regulation gap and routine work. Then, brainstorming, FMEA tool and risk priority number were applied for risk analysis and risk evaluation, respectively. Finally, the risk reduction described all the risk mitigation approaches. The high risks were caused by the desktop inspection pathway for non-PIC/S manufacturers and the lack of a stepwise approach in the document review. After implementing a stepwise review, the risk level were reduced to an acceptable level. This work can be a platform for the risk assessment of pharmaceutical quality systems.

DOI

10.56808/3027-7922.2790

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